A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501) in Women (V501-019)

Healthy Clinical Trial

Official title:

Safety, Immunogenicity, and Efficacy of Gardasil (V501 (Human Papilloma Virus [Types 6, 11, 16, 18] Recombinant Vaccine) in Mid-Adult Women - The FUTURE III (Females United to Unilaterally Reduce Endo/Ectocervical Cancer) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00090220
• Other study ID #: V501-019
• Secondary ID: 2004_013
• Status: Completed
• Phase: Phase 3
• First received: August 25, 2004
• Last updated: January 20, 2016
• Start date: June 2004
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is to assess the tolerability and efficacy of a vaccine being evaluated to reduce the incidence of human papillomavirus (HPV) infection and disease (external genital warts and vulvar, vaginal, and cervical cancer) in women.

Description:

The base study (V501-019) encompassed Day 1 through Month 7, during which time participants received randomly assigned Gardasil™ (qHPV vaccine) or placebo at Day 1, Month 2 and Month

6. Base study follow-up continued through Month 48.

The base study was extended in protocol V501-019-10 (EXT1). Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the base study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants were followed to EXT1 Month 7.

A Long Term Follow-Up (LTFU) extension study V501-019-20 (EXT2) will observe the long term safety, effectiveness, and immunogenicity of GARDASIL™ in 1,600 women who participated in the base protocol in Colombia. Data will be collected over a period of 6-10 years following subjects' enrollment in the original base protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3819
• Est. completion date: November 2015
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 24 Years to 45 Years

Eligibility

Inclusion Criteria:

• No history of genital warts, VIN, or VaIN

• Not pregnant and agrees to use effective contraception through Month 7 of the study

• Additional criteria will be discussed with you by the physician

Exclusion Criteria:

• Pregnant

• Concurrently enrolled in a clinical study involving collection of cervical specimens

• Previously received any HPV vaccine

• History of severe allergic reaction that required medical intervention

• Received any immune globulin or blood-derived products within 3 months prior to the first study injection

• History of splenectomy, known immune disorders, or receiving immunosuppressives

• Immunocompromised or diagnosed with HIV infection

• Known thrombocytopenia or any coagulation disorders that could contraindicate intramuscular injections

• History of recent or ongoing alcohol or drug abuse

• Prior treatment for genital warts, VIN, or VaIN

• History of cervical disease (ie, surgical treatment for cervical lesions)

• Hysterectomy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy
• Papillomavirus Infection
• Papillomavirus Infections

Intervention

Biological:
• Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Gardasil intramuscular injection in three 0.5 mL doses over 6 months.
• Comparator: Placebo
Placebo intramuscular injection in three 0.5 mL doses over 6 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (3)

Castellsagué X, Muñoz N, Pitisuttithum P, Ferris D, Monsonego J, Ault K, Luna J, Myers E, Mallary S, Bautista OM, Bryan J, Vuocolo S, Haupt RM, Saah A. End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant — View Citation

Muñoz N, Manalastas R Jr, Pitisuttithum P, Tresukosol D, Monsonego J, Ault K, Clavel C, Luna J, Myers E, Hood S, Bautista O, Bryan J, Taddeo FJ, Esser MT, Vuocolo S, Haupt RM, Barr E, Saah A. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24-45 years: a randomised, double-blind trial. Lancet. 2009 Jun 6;373(9679):1949-57. doi: 10.1016/S0140-6736(09)60691-7. Epub 2009 Jun 1. — View Citation

Velicer C, Zhu X, Vuocolo S, Liaw KL, Saah A. Prevalence and incidence of HPV genital infection in women. Sex Transm Dis. 2009 Nov;36(11):696-703. doi: 10.1097/OLQ.0b013e3181ad25ff. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Combined Incidence of HPV 16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer	HPV 16/18: The two types of HPV (types 16/18) were determined by PCR testing	Base Study: through Month 48	No
Primary	Combined Incidence of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, Vulvar Intraepithelial Neoplasia (VIN), Vaginal Intraepithelial Neoplasia (VaIN), Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, AIS, and Cervical Cancer	HPV 6/11/16/18: The four types of HPV (types 6/11/16/18) were determined by polymerase chain reaction (PCR) testing	Base Study: through Month 48	No
Primary	Number of Participants With Vaccine-Related Serious Adverse Events (SAEs)		Base Study: through Month 48	Yes
Secondary	Combined Incidence of HPV 6/11 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Adenocarcinoma In Situ (AIS), and Cervical Cancer	HPV 6/11: The two types of HPV (types 6/11) were determined by PCR testing	Base Study: through Month 48	No
Secondary	Combined Incidence of HPV 31/33/35/52/58 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer	This outcome measure was not analyzed because of diminished interest by experts in composite efficacy endpoints associated with these HPV types	Base Study: through Month 48	No